Quality Control Chemist I

1 day ago

Frederick, United States Collabera Full time

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Quality Control Chemist I

Contract: Frederick, Maryland, US

Salary: $32.00 Per Hour

Job Code: 353827

End Date: 2024-10-13
Days Left: 13 days, 3 hours left

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Title - Quality Control Chemist - I

Duration - 12months

Location - Frederick, MD , 21704

Job Roles & Responsibilities:
  • Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
  • Work with internal and external resources to maintain lab in an optimal state.
  • Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
  • Supply information to support generation of CoAs for product release.
  • Maintains laboratory instruments for calibration and routine maintenance
  • Author or revise SOPs, qualification/validation protocols and reports.
  • Asist with lab investigations regarding out of specifications (OOS) results.
  • Participate in determination of root cause for deviations related to analytical procedures.
  • Provide updates at daily and weekly meetings.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Gather metric information for use in continuous improvement of areas of responsibility.
  • Perform other duties as required.
Basic Qualifications:
  • Bachelor's Degree OR
  • AA Degree and 2+ years' experience in biotechnology or related field and Quality Control experience OR
  • High School Degree and 3+ years' experience in biotechnology or related field and Quality Control experience
Preferred Qualifications:
  • Strong knowledge of GMP, SOPs and quality control processes.
  • Identifying, writing, evaluating, and closing OOS's and investigations.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
  • Preferred: Experience in the biotech and/or pharmaceutical industry.
Back End Swing: Wed -Sat 1pm-11:30pm.
Front End Swing: Sun-Wed 1pm-11:30pm.

Important : For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7 weeks, the contractor is deployed onto their agreed upon shift.

Job Requirement
  • pcr
  • Flow cymetry
  • qpcr
  • Elisa
  • cell culture
  • assay
  • Laboratory
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Shivani Awasthi
  • shivani.awasthi@collabera.com


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